NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378729753
3 POUCH in 1 CARTON (0378-7297-53) / 1 BLISTER PACK in 1 POUCH (0378-7297-85) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A202086

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "38924c83-53aa-4279-8f0e-1a5d8f5fd8ad": {
      "match": "brand_token",
      "title": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS]",
      "spl_version": "7",
      "published_date": "2026-03-27"
    }
  },
  "productid": "0378-7297_4805e8cc-2bd9-6f76-cb1f-2d818160ac24",
  "productndc": "0378-7297",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "202086",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;0.4MG",
        "product_no": "001",
        "approval_date": "Apr 1, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE",
  "active_ingred_unit": null,
  "application_number": "ANDA202086",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone and ethinyl estradiol and ferrous fumarate",
  "start_marketing_date": "20161028",
  "active_numerator_strength": null
}

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